MAINSTREAM WATER PURIFICATION DEVICE

K012716 · Prismedical Corp. · NHV · May 7, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K012716
• Device Name: MAINSTREAM WATER PURIFICATION DEVICE
• Applicant: Prismedical Corp.
• Product Code: NHV · Gastroenterology, Urology
• Decision Date: May 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

To produce from EPA-grade drinking water, sterile purified water to be used within 24-hours of collection that is suitable for: - cleaning and rinsing open wounds; - infection control (cleaning equipment used in medical procedures, medical personnel's hands); - use as a diluent for enteral, nutritional, oral vaccine or oral drug preparations; and - all other uses of sterile purified water the practitioner, or clinician deems necessary. - Not for parenteral administration.

Device Story

MainStream™ Water Purification Device is a single-use system that processes approximately 3000 mL of EPA-grade drinking water into USP-grade sterile purified water. The device utilizes a multi-stage filtration and purification process, including prefiltration, depth filtration, deionization, and sterilizing membrane filtration. It is intended for use by clinicians or practitioners in medical settings to provide water for wound care, equipment cleaning, and as a diluent for non-parenteral preparations. The output is sterile water that must be used within 24 hours of collection. The device benefits patients and clinicians by providing a point-of-use source of sterile water for various medical procedures.

Clinical Evidence

Bench testing only. The device's safety and effectiveness were demonstrated by verifying that the end-product water meets the quality attributes and compendial standards of USP Sterile Purified Water, consistent with the predicate device.

Technological Characteristics

Single-use water purification device. Purification stages: prefiltration, depth filtration, deionization, and sterilizing membrane filtration. Produces USP-grade sterile purified water from EPA-grade drinking water. 260-mL device size provides up to 3 liters of output. Mechanical/physical filtration principle; no software or electronic components.

Indications for Use

Indicated for clinicians/practitioners requiring sterile purified water for wound cleaning/rinsing, infection control (equipment/hand cleaning), and as a diluent for enteral, nutritional, oral vaccine, or oral drug preparations. Not for parenteral administration.

Regulatory Classification

Identification

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Special Controls

*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Total Water Treatment Systems (TWTS) (K002045)

Submission Summary (Full Text)

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MAY 0 7 2002

K012716
Page 1 of 3

# 510(K) SUMMARY

As required by 512(1)(3)(A) of the Food, Drug and Cosmetic Act, PrISMedical Corporation is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." PrISMedical chooses to submit a summary of safety and effectiveness information.

| Applicant | PrISMedical Corporation<br>1100 Trancas Street, Suite 250<br>Napa, CA 94558<br>Phone: [phone]<br>FAX: [phone]<br>Contact Person: Elaine Alambra |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tradename | MainStream™ Water Purification Device |
| Device Generic Name | Water Purification Device |
| Classification / Classification Name | To be determined |
| Predicate Device | Total Water Treatment Systems (TWTS) – K002045 |
| Product Description | PrISMedical's MainStream™ Water Purification Device (WPD) is a single-use device that will take approximately 3000 mL of drinking water (EPA-grade or equivalent) and remove:<br><ul><li>particulates</li><li>dissolved solids</li><li>organics and inorganics</li><li>microbial contaminants</li><li>endotoxins</li></ul> |

PRISMEDICAL CORPORATION

510(K) SUMMARY - K012716

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K01276
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to produce water that meets the quality attributes of USP sterile purified water. This device comes in a 260-mL size to provide up to 3-liters of Sterile Purified Water, USP.

The device incorporates several complementary processes:

- Prefiltration .
- Depth filtration .
- Deionization .
- Sterilizing membrane filtration ●

To produce from EPA-grade drinking water, sterile purified water to be used within 24 hours of collection that is suitable for:

- cleaning and rinsing open wounds; .
- infection control (cleaning equipment used . in medical procedures, medical personnel's hands);
- use as a diluent for enteral, nutritional, oral � vaccine, or oral drug preparations; and
- all other uses of sterile purified water the . practitioner or clinician deems necessary.
- ◆ Not for parenteral administration.

Safety and functionality for this device were based solely on end product water characteristics. The materials, performance specifications and essential design characteristics of PrISMedical's MainStream™ water purification device are essentially identical to those of the Total Water Treatment Systems (TWTS) - K002045 predicate device. Both devices produce water

Intended use

Safety and Performance

PRISMEDICAL CORPORATION

510(K) SUMMARY - K012716

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K012716
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that meets the standards of USP Sterile Purified Water.

Conclusion

Based on the results of our testing and comparison of the requirements of the end product of the predicate device to compendial standards (Sterile Purified Water, USP), PrISMedical's MainStream™ Water Purification Device has been shown to be safe and effective for its intended use.

### 510(K) SUMMARY - K012716

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elaine Alambra Director, RA/QA PrISMedical Corporation 1100 Trancas Street NAPA CA 94558

MAY 0 7 2002

Re: K012716

Trade/Device Name: PrISMedical's MainStream™ Water Purification Device (WPD) Regulation Number: 21 CFR 876.5665 Regulation Name: Water purification system for hemodialysis

Regulatory Class: II Product Code: 78 NHV Dated: March 7, 2002 Received: March 11, 2002

Dear Ms. Alambra:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

# 510(k) Number (if known): K012716

Device Name:

Indications for Use:

MainStream™ Water Purification Device

To produce from EPA-grade drinking water, sterile purified water to be used within 24-hours of collection that is suitable for:

- cleaning and rinsing open wounds; .
- infection control (cleaning equipment used in . medical procedures, medical personnel's hands);
- use as a diluent for enteral, nutritional, oral . vaccine or oral drug preparations; and
- all other uses of sterile purified water the . practitioner, or clinician deems necessary.
- Not for parenteral administration. .

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

Nancyc brogdon
K812916